MAUDE Adverse Event Report: CARTIHEAL LTD. AGILI-C

Model Number	AGILI-C 7.5MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint effusion (4849)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was treated at (b)(6) 2024 with five agili-c 7.5mm implants.4 implants in the trochlea and 1 implant in the mfc (medial femoral condyle).Post-op knee x-rays indicated that mfc implant was protruding and not fully recessed below the articular cartilage to the level of the subchondral bone as instructed by the ifu.On (b)(6) 2024, the patient underwent arthroscopy due to post-operative recurring effusion of the knee.The mfc implant was removed due to implant loosening.No additional information is expected.Final report.
Additional Manufacturer Narrative
Analysis of production records found no issues associated with the lot/sn.It is the manufacturer's assessment that due to the proud positioning of the implant, once the patient returned to daily activities and regained full weight bearing, the implant was exposed to the weight bearing forces which might have led to micromovements, resulting in implant loosening.Implant loosening due to implant protrusion is a known risk.

• Brand Name: AGILI-C
• Common Device Name: AGILI-C
• Manufacturer (Section D): CARTIHEAL LTD.; 17 atir yeda; kfar saba, 44643 13; IS 4464313
• Manufacturer (Section G): CARTIHEAL; 17 atir yeda; kfar saba, 44643 13; IS 4464313
• Manufacturer Contact: adam waksman ; 3 reuten dr.; closter, NJ 07624
• MDR Report Key: 20260989
• Report Number: 3013881076-2024-00002
• Device Sequence Number: 15666216
• Product Code: QRU
• UDI-Device Identifier: 07290019087182
• UDI-Public: 07290019087182
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P210034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AGILI-C 7.5MM
• Device Catalogue Number: CH-075
• Device Lot Number: 144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White